Philoderm Aesthetics Bv
⚠️ Moderate Risk
FEI: 3008008256 • Breda, Noord-Brabant • NETHERLANDS
FEI Number
3008008256
Location
Breda, Noord-Brabant
Country
NETHERLANDSAddress
Heusing 16, , Breda, Noord-Brabant, Netherlands
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
NO PMA/PDP
The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
Frequently Asked Questions
What is Philoderm Aesthetics Bv's FDA import refusal history?
Philoderm Aesthetics Bv (FEI: 3008008256) has 1 FDA import refusal record(s) in our database, spanning from 12/28/2009 to 12/28/2009.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Philoderm Aesthetics Bv's FEI number is 3008008256.
What types of violations has Philoderm Aesthetics Bv received?
Philoderm Aesthetics Bv has been cited for 3 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Philoderm Aesthetics Bv come from?
All FDA import refusal data for Philoderm Aesthetics Bv is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.